Guide block for biopsy or surgical devices

ABSTRACT

One embodiment having features of the invention is directed to a guide block for an MRI device which has a block body with a proximal face, a distal face, and four parallel passageways extending between the two faces. The first passageway is centrally disposed, the second passageway is disposed vertical or horizontal to the first, the third passageway is located diagonal to the first and has a longitudinal opening in fluid communication with the first passageway, and the fourth passageway is diagonal to the first and in an opposite side of the body from the third passageway. In an alternative embodiment the guide block has at least one passageway that is not parallel to the longitudinal axis.

FIELD OF THE INVENTION

This invention relates generally to the field of medical devices andmethods. In particular, the invention relates to devices and methods forplacing a surgical device, such as a biopsy device, in a desiredlocation in relation to a patient during a biopsy procedure.

BACKGROUND OF THE INVENTION

In diagnosing and treating certain medical conditions, it is oftendesirable to perform a biopsy, in which a specimen or sample of tissueis removed for pathological examination, tests and analysis. As isknown, obtaining a tissue sample by biopsy and the subsequentexamination are typically employed in the diagnosis of cancers and othermalignant tumors, or to confirm that a suspected lesion or tumor is notmalignant. Examination of tissue samples taken by biopsy is ofparticular significance in the diagnosis and treatment of breast cancer.

Magnetic resonance imaging (MRI) is often used to locate the site withina breast where a potentially cancerous lesion or tumor is located.Interventional MRI is the magnetic resonance imaging technique (ofteninvolving real time imaging) that allows a surgeon to perform MRI-guidedtissue biopsy or surgery. One application of interventional MRI is toguide a surgeon during a biopsy or surgical operation on one or both ofthe breasts of a female patient.

Interventional MRI procedures typically require a magnetic resonancesignal detection coil which has large openings so that the surgeon canhave access to the surgical site through the coil with the biopsy deviceor other surgical devices. The MRI device may also include compressionplates to compress the breast. Compression plates contain needle guideholes to allow for proper placement of a needle during a needle biopsyor larger windows configured to hold guide blocks. Guide blocks haveblock bodies with needle guide holes or with larger openings to allowaccess for larger biopsy devices. The guide blocks assist the physicianwith proper placement and stabilization of the biopsy device during abiopsy procedure.

The compression plates are secured to the housing of the signaldetection coil. Markers, such as Vitamin E Capsules, which are highlyvisible under MRI device are placed on the compression plates and theposition of the markers relative to the suspect tissue is measured usingthe magnetic resonance images. The proper window of the compressionplate is then determined by finding the window in the compression platewhich is closest to the desired entry point.

For larger biopsy devices the guide blocks are usually cube-shaped andcontain about nine circular openings spaced in three rows of three. Dueto the configuration of the openings in the guide block and the largesize of some biopsy devices it is often difficult to precisely reach thedesired tissue location. Present guide blocks for larger biopsy devicesdo not allow for access to every area of tissue directly behind theblock. Thus, there is need in the art for improved guide blocks whichallow access to all areas of tissue directly behind the block.

SUMMARY OF THE INVENTION

This invention relates to placement of surgical devices during biopsyprocedures and in particular to devices and methods for placement of abiopsy device during a breast biopsy.

In one embodiment of the present invention a guide block has a body witha proximal face, a distal face and a longitudinal axis extending betweenthe proximal and distal faces. The guide block has four passagewayswhich are configured to slidably receive a surgical device, such as abiopsy device. The body of the guide block is configured to fit within agrid on the compression plate of a magnetic resonance imaging (MRI)device.

The four passageways extend longitudinally between the proximal anddistal faces of the block and are parallel to the longitudinal axis. Thefirst passageway is centrally disposed. The second passageway is locatedvertical or horizontal to the first passageway. The third passageway islocated diagonal to the first and has a longitudinal opening along itslength which is in fluid communication with the opening in the firstpassageway. The fourth passageway is located diagonal to the firstpassageway and on an opposite side of the body from the thirdpassageway. The configuration of the passageways allows for all tissuedirectly behind the guide block to be accessed by rotating the guideblock.

A method embodying features of the invention includes providing a guideblock having a body with four passageways which are configured withinthe body as described above and inserting the guide block into a gridopening of a magnetic resonance imaging device nearest to the suspecttissue and orienting the block to provide access to the desired locationin a patient.

In an alternative embodiment of the invention a guide block has a blockbody with a proximal face, a distal face, and a longitudinal axisextending between the proximal and distal faces. The guide block has atleast one passageway disposed within the body which is open along thelength thereof and which extends between the proximal and distal facesand are not parallel to the longitudinal axis. The configuration of theat least one passageway allows for access to tissue located outside ofthe exterior border of the compression plate.

A method embodying features of the invention includes providing a guideblock having a body with a proximal face, a distal face, and alongitudinal axis extending between the proximal and distal faces. Theguide block has at least one passageway disposed within the body whichextends between the proximal and distal faces and which is not parallelto the longitudinal axis. The method further includes inserting theguide block into a grid opening of an MRI nearest to the suspect tissueand selecting the orientation of the block 10 to provide access to thedesired location in the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 is a front elevational view of a device embodying features ofthe invention.

FIG. 2 is a rear elevational view of a device embodying features of theinvention.

FIG. 3 is a side elevational view of a device embodying features of theinvention.

FIG. 4 is a side elevational view of a device embodying features of theinvention.

FIG. 5 is a longitudinal cross sectional view of the device taken alonglines D-D in FIG. 2.

FIG. 6 is a longitudinal cross sectional view of the device taken alonglines B-B in FIG. 2.

FIG. 7 is a elevational view of a magnetic resonance imaging devicehaving compression plates with grids configured to receive devicesembodying features of the invention.

FIG. 8 is a front elevational view of a device embodying features of theinvention.

FIG. 9 is a rear elevational view of a device embodying features of theinvention.

FIG. 10 is a longitudinal cross sectional view of a device shown inFIGS. 8 and 9.

FIG. 11 is a side view of a device embodying features of the inventionwithin the grid of a compression plate.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1-6 are perspective views of devices embodying features of theinvention. A device embodying features of the invention includes a guideblock 10 having a body 12 with a proximal face 14, a distal face 16 anda longitudinal axis 18 extending between the proximal 14 and distal 16faces. The guide block 10 has four passageways 20 which extendlongitudinally between the proximal 14 and distal 16 faces of the guideblock 10 and which are parallel to the longitudinal axis 18. Eachpassageway 20 of the guide block 10 is configured to slidably receive asurgical device, such as the biopsy device in U.S. Pat. No. 6,454,727assigned to the assignee of the present invention. Preferably thepassageways 20 are cylindrically shaped.

The first passageway 22 is centrally disposed. The second passageway 24is located vertical or horizontal to the first passageway 22 andparallel to the longitudinal axis. The third passageway 26 is locateddiagonal to the first passageway 22, and is parallel to the longitudinalaxis. The third passageway also has a longitudinal opening along itslength which is in fluid communication with the opening in the firstpassageway 22. The fourth passageway 28, is parallel to the longitudinalaxis, and is located diagonal to the first passageway 22 and in anopposite side of the body 12 from the diagonal location of the thirdpassageway 26. Two suitable configurations of the passageways 20 withinthe guide block 10, shown in FIGS. 1 and 2, are mirror images of oneanother.

The guide block 10 is configured to be used in conjunction with alocating or imaging devices such as a magnetic resonance imaging (MRI)device. An example of an MRI breast coil and grid device is the Invivo 7channel breast biopsy array 800239 in FIG. 7 (photo obtained fromwww.mridevices.com/products/CoilProduct Detail.aspx?ID=43). A MRI device30 used to detect suspect tissue in breasts has a detection coil 32 withlarge openings 34. The MRI device 30 also includes compression plates 36to compress the breast. The compression plates 36 are secured to thehousing of the detection coil 32 and include grid 38 with grid openings40 so that the surgeon can have access to the surgical site through thecoil 32 with the biopsy device or other surgical devices. The gridopenings 40 have four sides 42 and are configured to receive the guideblocks 10 and hold them in place. Preferably the guide block 10 has aproximal face 14 with four equal sides 44. When the guide block 10 isplaced into the grid opening 40 any one of the four sides 44 of theproximal face 14 of the guide block may align with any one of the foursides 42 of a grid opening 40 to secure the block within the grid 38.

The location of the passageways 20 within the block 10 allows a biopsydevice to gain access to all areas of tissue behind the block 10. Byrotating the block before placing it within the grid opening 40, eacharea of tissue behind the block 10 will, at some point, be accessiblethrough one of the four passageways 20.

In some embodiments the proximal face 14 has a larger surface area thanthe surface area of the distal face 16 and forms a radially projectingshoulder 46 which prevents the block from advancing too far past thegrid opening 40. The shoulder 46 extends about 0.02 inches to about 0.06inches from the outside wall of the body.

In one embodiment of the device each side 44 of the proximal face 14 ofthe device is about 0.4 inches to about 1.3 inches long, typically about0.9 inches long. In this embodiment the center of the first passageway22 is about 0.2 inches to about 0.6 inches from each side 44 of theproximal face, typically about 0.4 inches from each side 44. The centerof the second passageway 24 is about to 0.1 inches about 0.35 inchesfrom the center of the first passageway 22, typically about 0.2 inchesaway from the center of the first passageway 22. The center of the thirdpassageway 26 is about 0.1 inches to about 0.25 inches, typically about0.15 inches away from the center of the first passageway 22. The centerof the fourth passageway 28 is about 0.15 inches to about 0.5 inchesaway from the center of the first guide passageway 22, typically about0.3 inches. The length of block 10 is about 0.5 to about 0.9, typicallyabout 0.8 inches.

In one embodiment the guide block 10 includes at least one tab 48 on theperimeter of the body which extends between the proximal and distalfaces and which has a distal portion near the distal face of the blockwith a raised area 50. The tabs 48 are configured to allow the raisedarea 50 to bend inward toward the body when placing the block within agrid opening 40. Once in the opening the raised area 50 extends radiallyoutward and presses against the sides 42 of the grid opening 40 as ameans to maintain its position.

In some embodiments the tab is about 0.05 inches to about 0.15 incheswide, preferably about 0.10 inches wide. The tabs range in length fromabout 0.25 to about 0.8 inches long. In some embodiments of theinvention at least one tab 48 is about 0.05 to about 0.2 inches wide,preferably about 0.15 inches wide.

The guide block 10 may be formed from a plastic such as MAKROLON®, apolycarbonate from Bayer Material Sciences a division of Bayer AG.

A method embodying features of the invention includes providing a guideblock 10 having a body 12 with four passageways 20 which are configuredwithin the body. The first passageway 22 is centrally disposed. Thesecond passageway 24 is located vertical or horizontal to the firstpassageway 22 and parallel to the longitudinal axis. The thirdpassageway 26 is located diagonal to the first passageway 22, and isparallel to the longitudinal axis. The third passageway also has alongitudinal opening along its length which is in fluid communicationwith the opening in the first passageway 22. The fourth passageway 28,is parallel to the longitudinal axis, and is located diagonal to thefirst passageway 22 and in on opposite side of the body 12 from thediagonal location of the third passageway 26. The method furtherincludes inserting the guide block into a grid opening 40 of an MRIdevice 30 nearest to the suspect tissue and selecting the orientation ofthe block 10 to provide access to the desired location in patient.

In some methods embodying features of the invention an imaging deviceconfigured to locate suspect tissue is provided to locate the suspecttissue. Preferably the imaging device is magnetic resonance imaging 30.

An alternative embodiment of the invention illustrated in FIGS. 8-11include a guide block 52 having a body 54 with a proximal face 56, adistal face 58, and a longitudinal axis 60 extending between theproximal face 56 and distal face 58. The guide block 52 has at least onepassageway 62 disposed within the body which extends between theproximal and distal faces and are not parallel to the longitudinal axis.This embodiment provides access to tissue located outside of theexterior border of the grid 64 of the compression plate 66.

A method embodying features of the invention includes providing a guideblock 52 having a body 54 with a proximal face 56 a distal face 58, anda longitudinal axis 60 extending between the proximal and distal faces.The guide block 52 has at least one passageway 62 disposed within thebody 54 which extends between the proximal 56 and distal faces 58 andwhich is not parallel to the longitudinal axis 60. The method furtherincludes inserting the guide block 52 into a grid opening 68 of acompression plate 70 nearest to the suspect tissue and selecting theorientation of the block 52 to provide access to the desired location inthe patient.

While particular forms of the invention have been illustrated anddescribed herein, it will be apparent that various modifications andimprovements can be made to the invention. Moreover, individual featuresof embodiments of the invention may be shown in some drawings and not inothers, but those skilled in the art will recognize that individualfeatures of one embodiment of the invention can be combined with any orall the features of another embodiment. Accordingly, it is not intendedthat the invention be limited to the specific embodiments illustrated.It is therefore intended that this invention be defined by the scope ofthe appended claims as broadly as the prior art will permit.

Terms such as “element”, “member”, “component”, “device”, “means”,“portion”, “section”, “steps”, “means” and words of similar import whenused herein shall not be construed as invoking the provisions of 35U.S.C §112(6) unless the following claims expressly use the terms“means” or “step” followed by a particular function without reference toa specific structure or action. All patents and all patent applicationsreferred to above are hereby incorporated by reference in theirentirety.

1-33. (canceled)
 34. A method comprising: a. providing a guide blockwith a body which has a proximal face, a distal face, a length betweenthe proximal and distal faces, a longitudinal axis extending between theproximal and distal faces and which has i. a first passageway in theguide block which is centrally disposed within the body, which is openalong the length thereof, which is configured to receive a tissueaccessing device, and which is parallel to the longitudinal axis, ii. asecond passageway in the guide block which is disposed within the bodyand which is located vertical or horizontal to the first passageway,which is configured to receive the tissue accessing device, and which isparallel to the longitudinal axis, iii. a third passageway in the guideblock which is disposed within the body, which is located diagonal tothe first passageway and which has a longitudinal opening along a lengththereof that is in fluid communication with the opening in the firstpassageway, which is configured to receive the tissue accessing device,and which is parallel to the longitudinal axis, and iv. a fourthpassageway which is disposed within the body, which is located diagonalto the first passageway and in an opposite side of the body from thediagonal orientation of the third passageway, which is configured toreceive the tissue accessing device, and which is parallel to thelongitudinal axis; and b. selecting the orientation of the block toprovide access to a desired location in the patient; c. inserting theguide block into a grid opening of a magnetic resonance imaging devicenearest to suspect tissue.
 35. The method of claim 34 includinginserting the tissue accessing device into the passageway nearest to thedesired location within the patient.
 36. The method of claim 35including operating the device to obtain a biopsy specimen.
 37. Themethod of claim 34 wherein an imaging device configured to locatesuspect tissue is provided to locate suspect tissue. 38-42. (canceled)43. A method comprising: a. providing a guide block with a body whichhas i. a proximal face, a distal face, a length between the proximal anddistal faces and a longitudinal axis extending between the proximal anddistal faces, and ii. at least one passageway disposed within the bodywhich is open along the length thereof, which extends between theproximal and distal faces, which is configured to receive a tissueaccessing device and which is not parallel to the longitudinal axis; b.selecting the orientation of the block to provide access to a desiredlocation in the patient; and c. inserting the guide block into a gridopening of a magnetic resonance imaging device nearest to suspecttissue.